U.S. patent application number 10/143353 was filed with the patent office on 2003-11-13 for intra-bronchial obstructing device that permits mucus transport.
This patent application is currently assigned to Spiration, Inc.. Invention is credited to Alferness, Clifton A., DeVore, Lauri J., Dillard, David H., Gonzalez, Hugo X..
Application Number | 20030212412 10/143353 |
Document ID | / |
Family ID | 29400108 |
Filed Date | 2003-11-13 |
United States Patent
Application |
20030212412 |
Kind Code |
A1 |
Dillard, David H. ; et
al. |
November 13, 2003 |
Intra-bronchial obstructing device that permits mucus transport
Abstract
An obstructive device prevents air from being inhaled into a
lung portion to collapse the lung portion while providing mucus
transport from the lung portion. When placed in an air passageway
serving the lung portion, the obstructing member defines a pathway
for mucus transport between the obstructing member and the air
passageway. The device may include a tubular-shaped anchor to
retain the device in the air passageway. A pathway for mucus
transport is provided between a portion of the anchor and a portion
of the obstructing device.
Inventors: |
Dillard, David H.; (Redmond,
WA) ; Alferness, Clifton A.; (Redmond, WA) ;
DeVore, Lauri J.; (Seattle, WA) ; Gonzalez, Hugo
X.; (Woodinville, WA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Assignee: |
Spiration, Inc.
|
Family ID: |
29400108 |
Appl. No.: |
10/143353 |
Filed: |
May 9, 2002 |
Current U.S.
Class: |
606/108 |
Current CPC
Class: |
A61B 17/12136 20130101;
A61B 2017/1205 20130101; A61B 17/12104 20130101; A61B 17/12172
20130101; A61B 17/12022 20130101; A61F 2002/043 20130101; A61B
17/12159 20130101 |
Class at
Publication: |
606/108 |
International
Class: |
A61F 011/00 |
Claims
What is claimed is:
1. An intra-bronchial device adapted to be placed in an air
passageway to collapse a lung portion associated with the air
passageway, the device comprising an obstructing member that
prevents air from being inhaled into the lung portion to collapse
the lung portion and that permits mucus transport from the lung
portion.
2. The device of claim 1, wherein the obstructing member, when
placed in the air passageway, defines at least one peripheral
pathway providing for mucus transport.
3. The device of claim 1, wherein the obstructing member, when
placed in the air passageway, defines at least one peripheral
pathway providing for mucus transport between a portion of the
exterior perimeter surface of the obstructing member and a portion
of the interior surface of the air passageway.
4. The device of claim 1, wherein the obstructing member allows air
to pass from the lung portion to be collapsed.
5. The device of claim 1, wherein the obstructing member includes a
flexible membrane impervious to air flow.
6. An intra-bronchial device adapted to b e placed in an air
passageway to collapse a lung portion associated with the air
passageway, the device comprising: an anchor that retains the
device in the air passageway; and an obstructing member carried by
the anchor that prevents air from being inhaled into the lung
portion to collapse the lung portion and being arranged to permit
mucus transport from the lung portion.
7. The device of claim 6, wherein the anchor is arranged to
maintain continuous contact with the interior perimeter of the air
passageway.
8. The device of claim 6, wherein the anchor comprises a
ring-shaped member having an interior surface.
9. The device of claim 6, wherein the anchor comprises a generally
tubular member.
10. The device of claim 6, wherein the obstructing member is
mounted on the anchor to define at least one peripheral pathway
that provides for mucus transport.
11. The device of claim 6, wherein the obstructing member is
mounted on the anchor to form at least one peripheral pathway
between an interior perimeter surface portion of the anchor and an
exterior perimeter surface portion of the obstructing member.
12. The device of claim 6, wherein the obstructing member allows
air to pass from t he lung portion to be collapsed.
13. The device of claim 6, wherein the anchor provides for
re-epithelialization, allowing mucus transport along at least one
pathway between the anchor and the obstructing member.
14. The device of claim 6, wherein the obstructing member includes
a flexible membrane impervious to air flow, the membrane being
secured at selected areas around the interior perimeter of the
anchor to form at least one mucus transport pathway.
15. A method of reducing the size of a lung by collapsing a portion
of the lung while permitting mucus transport, the method including
the step of placing an obstructing member in an air passageway
communicating with the portion of the lung to be collapsed to
permit mucus transport past the obstructing member while precluding
air from being inhaled into the portion of the lung.
16. The method of claim 15, wherein the placing step includes
providing at least one peripheral pathway between an interior
perimeter surface portion of the air passageway and an exterior
perimeter surface portion the obstructing member.
17. The method of claim 15, wherein the obstructing member allows
air to pass from the lung portion to be collapsed.
18. The method of claim 15, wherein the obstructing member further
includes a flexible membrane impervious to air flow.
19. A method of reducing the size of a lung by collapsing a portion
of the lung while permitting mucus transport, the method including
the steps of: placing an anchor in an air passageway communicating
with the portion of the lung; and mounting an obstructing member on
the anchor to define at least one pathway that permits mucus
transport past the obstructing member, the obstructing member
precludes air from being inhaled into the portion of the lung.
20. The method of claim 19, wherein the mounting step includes
providing at least one peripheral pathway between an interior
perimeter surface portion of the anchor and an exterior perimeter
surface portion of the obstructing member for permitting mucus
transport.
21. The method of claim 19, wherein the obstructing member allows
air to pass from the lung portion to be collapsed.
22. The method of claim 19, wherein the obstructing member includes
a flexible membrane impervious to air flow.
23. The method of claim 19, wherein the anchor comprises a
ring-shaped member having an interior surface.
24. The method of claim 19, wherein the anchor comprises a
generally tubular member.
25. An apparatus for reducing the size of a lung by collapsing a
portion of the lung while permitting mucus transport, the apparatus
comprising: obstructing means for obstructing an air passageway
communicating with the portion of the lung, the obstructing means
being dimensioned for insertion into the air passageway, for
precluding air to be inhaled through the air passageway into the
lung portion, and for permitting mucus transport from the lung
portion while maintaining the preclusion of inhaled air from
flowing into the lung portion to collapse the portion of the
lung.
26. The apparatus of claim 25, wherein the obstructing means is
dimensioned to define at least one peripheral pathway for providing
mucus transport when placed in the air passageway.
27. The apparatus of claim 25, further including anchor means for
anchoring the obstructing member in the air passageway.
28. The apparatus of claim 27, wherein the obstructing means is
mounted on the anchor means to define at least one peripheral
pathway between the anchoring means and the obstructing means for
permitting mucus transport.
29. A system for reducing the size of a lung by collapsing a
portion of the lung while permitting mucus transport, the system
comprising: an intra-bronchial device adapted to be placed in an
air passageway to collapse a lung portion associated with the air
passageway, the device including an obstructing member that
prevents air from being inhaled into the lung portion while
permitting mucus transport from the lung portion; and an apparatus
that places the intra-bronchial device in the air passageway.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention is generally directed to a device,
system, and method for treating Chronic Obstructive Pulmonary
Disease (COPD). The present invention is more particularly directed
to a providing an intra-bronchial obstruction while permitting
mucus transport and clearance from a collapsed lung portion.
[0002] COPD has become a major cause of morbidity and mortality in
the United States over the last three decades. COPD is
characterized by the presence of airflow obstruction due to chronic
bronchitis or emphysema. The airflow obstruction in COPD is due
largely to structural abnormalities in the smaller airways.
Important causes are inflammation, fibrosis, goblet cell
metaplasia, and smooth muscle hypertrophy in terminal
bronchioles.
[0003] The incidence, prevalence, and health-related costs of COPD
are on the rise. Mortality due to COPD is also on the rise. In
1991, COPD was the fourth leading cause of death in the United
States and had increased 33% since 1979.
[0004] COPD affects the patient's whole life, producing increasing
disability. It has three main symptoms: cough; breathlessness; and
wheeze. At first, breathlessness may be noticed when running for a
bus, digging in the garden, or walking uphill. Later, it may be
noticed when simply walking in the kitchen. Over time, it may occur
with less and less effort until it is present all of the time.
[0005] COPD is a progressive disease and currently has no cure.
Current treatments for COPD include the prevention of further
respiratory damage, pharmacotherapy, and surgery. Each is discussed
below.
[0006] The prevention of further respiratory damage entails the
adoption of a healthy lifestyle. Smoking cessation is believed to
be the single most important therapeutic intervention. However,
regular exercise and weight control are also important. Patients
whose symptoms restrict their daily activities or who otherwise
have an impaired quality of life may require a pulmonary
rehabilitation program including ventilatory muscle training and
breathing retraining. Long-term oxygen therapy may also become
necessary.
[0007] Pharmacotherapy may include bronchodilator therapy to open
up the airways as much as possible or inhaled beta-agonists. For
those patients who respond poorly to the foregoing or who have
persistent symptoms, ipratropium bromide may be indicated. Further,
courses of steroids, such as corticosteroids, may be required.
Lastly, antibiotics may be required to prevent infections and
influenza and pneumococcal vaccines may be routinely administered.
Unfortunately, there is no evidence that early, regular use of
pharmacotherapy will alter the progression of COPD.
[0008] About 40 years ago, it was first postulated that the
tethering force that tends to keep the intrathoracic airways open
was lost in emphysema and that by surgically removing the most
affected parts of the lungs, the force could be partially restored.
Although the surgery was deemed promising, the procedure was
abandoned.
[0009] The lung volume reduction surgery (LVRS) was later revived.
In the early 1990's, hundreds of patients underwent the procedure.
However, the number of procedures has declined because Medicare
stopped reimbursing for LVRS. The procedure is currently under
review in controlled clinical trials. However, preliminary data
indicates that patients benefited from the procedure in terms of an
increase in forced expiratory volume, a decrease in total lung
capacity, and a significant improvement in lung function, dyspnea,
and quality of life.
[0010] Improvements in pulmonary function after LVRS have been
attributed to at least four possible mechanisms. These include
enhanced elastic lung recoil, correction of ventilation/perfusion
mismatch, improved efficiency of respiratory muscaulature, and
improved right ventricular filling.
[0011] Lastly, lung transplantation is also a therapeutic option.
Today, COPD is the most common diagnosis for which lung
transplantation is considered. Unfortunately, this consideration is
given for only those with advanced COPD. Given the limited
availability of donor organs, lung transplant is far from being
available to all patients.
[0012] The inventions disclosed and claimed in U.S. Pat. Nos.
6,258,100 and 6,293,951, both of which are incorporated herein by
reference, provide an improved therapy for treating COPD. The
therapy includes non-surgical apparatus and procedures for reducing
lung volume by permanently obstructing the air passageway that
communicates with the portion of the lung to be collapsed. An
obstruction is placed in the air passageway that prevents inhaled
air from flowing into the portion of the lung to be collapsed. Lung
volume reduction with concomitant improved pulmonary function may
be obtained without the need for surgery. Various other apparatus
and techniques may exist for permanently obstructing the air
passageway.
[0013] Mucus transport in normal airways includes mucus transport
by the mucociliary mechanism and coughing mechanism. It carries
bacteria out of the lungs and prevents pneumonia. Although various
apparatus and methods have been conceived for permanently
obstructing an air passageway and collapsing a portion of a lung,
none addresses a potential complication where the permanent
obstruction may interfere with mucus transport by mucociliary or
coughing transport mechanism.
[0014] In view of the foregoing, there is a need in the art for a
new and improved apparatus and method for permanently obstructing
an air passageway that minimizes the potential complication to or
interference with mucus transport. The present invention is
directed to a device, system, and method which provide such an
improved apparatus and method for treating COPD.
SUMMARY OF THE INVENTION
[0015] The present invention provides an apparatus and method for
use in a treatment regime that treats COPD by reducing the size of
a lung by permanently collapsing at least a portion of the lung.
The invention permits mucus transport past an intra-bronchial
obstructing device used to collapse the lung portion.
[0016] The present invention provides an intra-bronchial device
adapted to be placed in an air passageway to collapse a lung
portion associated with the air passageway. The device includes an
obstructing member that both prevents air from being inhaled into
the lung portion to collapse the lung portion, and permits mucus
transport from the lung portion. Further, the obstructing member,
when placed in the air passageway, may define at least one
peripheral pathway providing for mucus transport. At least one
peripheral pathway providing for mucus transport may be between a
portion of the exterior perimeter surface of the obstructing member
and a portion of the interior surface of the air passageway. The
obstructing member may allow air to pass from the lung portion to
be collapsed. The obstructing member may include a flexible
membrane impervious to air flow.
[0017] In accordance with an additional embodiment of the
invention, the invention provides an intra-bronchial device adapted
to be placed in an air passageway to collapse a lung portion
associated with the air passageway. The device of the additional
embodiment comprises an anchor that retains the device in the air
passageway, and an obstructing member carried by the anchor that
prevents air from being inhaled into the lung portion to collapse
the lung portion and being arranged to permit mucus transport from
the lung portion. The anchor may be arranged to maintain continuous
contact with the interior perimeter of the air passageway. The
anchor may comprise a ring-shaped member having an interior
surface. Furthermore, the anchor may comprise a generally tubular
member. The obstructing member may be mounted on the anchor to
define at least one peripheral pathway that provides for mucus
transport. In an alternative embodiment, the obstructing member is
mounted on the anchor to form at least one peripheral pathway
between a portion of an interior perimeter surface of the anchor
and a portion of the exterior perimeter surface of the obstructing
member. In a further alternative embodiment, the anchor provides
for re-epithelialization, allowing mucus transport along at least
one pathway between the anchor and the obstructing member. The
obstructing member may allow air to pass from the lung portion to
be collapsed. The obstructing member may also include a flexible
membrane impervious to air flow, the membrane being secured at
selected areas around the interior perimeter of the anchor to form
at least one mucus transport pathway.
[0018] The present invention still further provides a method for
reducing the size of a lung by collapsing a portion of the lung
while permitting mucus transport. The method includes the step of
placing an obstructing member in an air passageway communicating
with the portion of the lung to be collapsed, the obstructing
member being arranged to permit mucus transport past the
obstructing member while precluding air from being inhaled into the
portion of the lung. The placing step may include providing at
least one peripheral pathway between an interior perimeter surface
portion of the air passageway and an exterior perimeter surface
portion the obstructing member. The obstructing member of the
method may allow air to pass from the lung portion to be collapsed.
The obstructing member of the method may further include a flexible
membrane impervious to air flow.
[0019] In yet another embodiment, the invention provides a method
for reducing the size of a lung by collapsing a portion of the lung
while permitting mucus transport. The method includes the steps of
placing an anchor in an air passageway communicating with the
portion of the lung, and mounting an obstructing member on the
anchor to define at least one pathway that permits mucus transport
past the obstructing member. The obstructing member precludes air
from being inhaled into the portion of the lung. The mounting step
may include providing at least one peripheral pathway between an
interior perimeter surface portion of the anchor and an exterior
perimeter surface portion for permitting mucus transport. The
obstructing member of the method may allow air to pass from the
lung portion to be collapsed. The obstructing member of the method
may further includes a flexible membrane impervious to air flow.
The anchor of the method may comprise a ring-shaped member having
an interior surface. Furthermore, the anchor may comprise a
generally tubular member.
[0020] In a further embodiment, the invention provides an apparatus
for reducing the size of a lung by collapsing a portion of the lung
while permitting mucus transport. The apparatus includes an
obstructing means for obstructing an air passageway communicating
with the portion of the lung, the obstructing means being
dimensioned for insertion into the air passageway, for precluding
air to be inhaled through the air passageway into the lung portion,
and for permitting mucus transport from the lung portion while
maintaining the preclusion of inhaled air from flowing into the
lung portion to collapse the portion of the lung. The obstructing
means may be dimensioned to define at least one peripheral pathway
for providing mucus transport when placed in the air passageway.
The apparatus may further include an anchor means for anchoring the
obstructing member in the air passageway. The obstructing means may
be mounted on the anchor means to define at least one peripheral
pathway between the anchoring means and the obstructing means for
permitting mucus transport.
[0021] In yet a further embodiment, the invention provides a system
for reducing the size of a lung by collapsing a portion of the lung
while permitting mucus transport. The system comprises an
intra-bronchial device adapted to be placed in an air passageway to
collapse a lung portion associated with the air passageway, the
device including an obstructing member that prevents air from being
inhaled into the lung portion while permitting mucus transport from
the lung portion, and an apparatus that places the intra-bronchial
device in the air passageway.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] The features of the present invention which are believed to
be novel are set forth with particularity in the appended claims.
The invention, together with further objects and advantages
thereof, may best be understood by making reference to the
following description taken in conjunction with the accompanying
drawings, in the several figures of which like referenced numerals
identify like elements, and wherein:
[0023] FIG. 1 is a simplified sectional view of a thorax
illustrating a healthy respiratory system;
[0024] FIG. 2 is a simplified sectional view of a thorax
illustrating the mucus transport system in a respiratory
system;
[0025] FIG. 3 is a sectional view similar to FIG. 1 but
illustrating a respiratory system suffering from COPD, and an
initial step in placing an obstructing member;
[0026] FIG. 4 illustrates a further step in a method for placement
of an obstructing member in a bronchial sub-branch;
[0027] FIG. 5 is a perspective view, partly in section, and to an
enlarged scale, illustrating an obstructing member positioned in an
air passageway for sealing the lung portion;
[0028] FIG. 6 illustrates additional details concerning a bronchial
wall, a mucus layer, and an obstructing member;
[0029] FIG. 7 is a longitudinal section view that illustrates
additional detail related to the contact areas formed by the
obstructing member and mucus layer;
[0030] FIG. 8 illustrates additional details of an obstructing
member;
[0031] FIG. 9 is a cross-sectional view illustrating an obstructing
member placed in an air passageway and permitting mucus
transport;
[0032] FIG. 10 illustrates a stent-like anchor and an obstructing
member in position within an air passageway;
[0033] FIG. 11 illustrates a stent-like anchor disposed on a
bronchial wall, with the obstructing member not being shown to
better illustrate the re-epithelialization process;
[0034] FIG. 12 illustrates a cross-sectional view of an air
passageway with a stent-like anchor and an obstructing member
placed in an air passageway, and providing for mucus transport;
[0035] FIG. 13 illustrates a longitudinal sectional view of a
stent-like anchor and an obstructing member placed in an air
passageway, taken through two coupling areas; and
[0036] FIG. 14 illustrates a longitudinal sectional view of a
stent-like anchor and an obstructing member placed in an air
passageway, taken midway through two relatively flat areas of the
obstructing member.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0037] Referring now to FIG. 1, it is a sectional view of a healthy
respiratory system. The respiratory system 20 resides 25 within the
thorax 22, which occupies a space defined by the chest wall 24 and
the diaphragm 26.
[0038] The respiratory system 20 includes the trachea 28, the left
mainstem bronchus 30, the right mainstem bronchus 32, the bronchial
branches 34, 36, 38, 40, and 42 and sub-branches 44, 46, 48, and
50. The respiratory system 20 further includes left lung lobes 52
and 54 and right lung lobes 56, 58, and 60. Each bronchial branch
and sub-branch communicates with a respective different portion of
a lung lobe, either the entire lung lobe or a portion thereof. As
used herein, the term "air passageway" is meant to denote either a
bronchi or bronchiole, and typically means a bronchial branch or
sub-branch which communicates with a corresponding individual lung
lobe or lung lobe portion to provide inhaled air thereto or conduct
exhaled air therefrom.
[0039] Characteristic of a healthy respiratory system is the arched
or inwardly arcuate diaphragm 26. As the individual inhales, the
diaphragm 26 straightens to increase the volume of the thorax 22.
This causes a negative pressure within the thorax. The negative
pressure within the thorax in turn causes the lung lobes to fill
with air. When the individual exhales, the diaphragm returns to its
original arched condition to decrease the volume of the thorax. The
decreased volume of the thorax causes a positive pressure within
the thorax which in turn causes exhalation of the lung lobes.
[0040] FIG. 2 illustrates the mucus transport system in a normal
lung. Many pollution particles are inhaled as a person breathes,
and the air passageways function as a very effective filter. The
mucus transport system 55 functions as a self-cleaning mechanism
for all air passageways, including the lungs. The mucus transport
system 55 is a primary method for mucus clearance from distal
portions of the lungs, and further constitutes a primary immune
barrier for the lungs. The surface of air passageways is formed
with respiratory epithelium (or epithelial membrane), which is
covered with cilia and coated with mucus. As part of the mucus
transport system 55, the mucus entraps many inhaled particles and
moves them toward the larynx 28. Mucus transport system 55 includes
the metachronal ciliary beat of cilia on the respiratory epithelium
that moves a continuous carpet of mucus and entrapped particles
from the distal portions of the lungs past the larynx 28 and to the
pharynx for expulsion from the respiratory system. The mucus
transport system 55 also includes the coughing transport mechanism.
The explosive expiration of a cough helps clear the lungs of
secretions and foreign bodies. "Mucus transport" as used in the
specifications, including the description and claims, includes the
mucociliary transport system and the coughing transport
mechanism.
[0041] In contrast to the healthy respiratory system of FIG. 1,
FIG. 3 illustrates a respiratory system suffering from COPD. Here
it may be seen that the lung lobes 52, 54, 56, 58, and 60 are
enlarged and that the diaphragm 26 is not arched but substantially
straight. Hence, this individual is incapable of breathing normally
by moving the diaphragm 26. Instead, in order to create the
negative pressure in the thorax 22 required for breathing, this
individual must move the chest wall outwardly to increase the
volume of the thorax. This results in inefficient breathing causing
these individuals to breathe rapidly with shallow breaths.
[0042] It has been found that the apex portions 62 and 66 of the
upper lung lobes 52 and 56, respectively, are most affected by
COPD. Hence, bronchial sub-branch obstructing devices are generally
employed for treating the apex 66 of the right, upper lung lobe 56.
However, as will be appreciated by those skilled in the art, the
present invention may be applied to any lung portion without
departing from the present invention. As will be further
appreciated by those skilled the in art, the present invention may
be used with any type of obstructing member to permit mucus
transport. The inventions disclosed and claimed in U.S. Pat. Nos.
6,258,100 and 6,293,951, both of which are incorporated herein by
reference, provide an improved therapy for treating COPD by
obstructing an air passageway using an intrabronchial valve or
plug. The present invention may be used with the apparatus, system,
and methods of these patents as will be briefly described in
conjunction with the disclosure of the preferred embodiments of the
present invention.
[0043] The insertion of an obstructing member treats COPD by
deriving the benefits of lung volume reduction surgery without the
need of performing the surgery. The treatment contemplates
permanent collapse of a lung portion. This leaves extra volume
within the thorax for the diaphragm to assume its arched state for
acting upon the remaining healthier lung tissue. As previously
mentioned, this should result in improved pulmonary function due to
enhanced elastic recoil, correction of ventilation/perfusion
mismatch, improved efficiency of respiratory musculature, and
improved right ventricle filling. The present invention supports
the use of intra-bronchial plugs to treat COPD by allowing mucus
transport to continue after insertion of the obstructing device,
thus reducing entrapment of bacteria distal to the obstructing
device.
[0044] FIG. 3 also illustrates a step in COPD treatment using an
obstructing-member. Treatment is initiated by feeding a conduit or
catheter 70 down the trachea 28, into the right mainstem bronchus
32, into the bronchial branch 42 and into and terminating within
the sub-branch 50. The sub-branch 50 is the air passageway that
communicates with the lung portion 66 to be treated. The catheter
70 is preferably formed of flexible material such as polyethylene.
Also, the catheter 70 is preferably preformed with a bend 72 to
assist the feeding of the catheter from the right mainstem bronchus
32 into the bronchial branch 42, or could be deformed to conform to
different curvatures and angles of the bronchial tree.
[0045] FIG. 4 illustrates a further step in a method for placing an
obstructing member 90 in a bronchial sub-branch using a catheter.
The invention disclosed herein is not limited to use with the
particular method illustrated herein. Catheter 70 may be used alone
to perform the insertion, may be extended from a bronchoscope, or
used in conjunction with a bronchoscope. For purposes of this
description, the insertion will be described with reference to only
the catheter 70. The invention disclosed herein is not limited to
use with the particular method illustrated herein. Catheter 70
includes an optional inflatable sealing member 74 for use with a
vacuum to collapse lung portion 66 prior to insertion of
obstructing member 90. The obstructing member 90 may be formed of
resilient or collapsible material to enable the obstructing member
90 to be fed through the conduit 70 in a collapsed state. The
stylet 92 is used to push the obstructing member 90 to the end 77
of the catheter 70 for placing the obstructing member 90 within the
air passageway 50 adjacent to the lung portion 66 to be permanently
collapsed. Optional sealing member 74 is withdrawn after
obstructing member 90 is inserted.
[0046] FIG. 5 illustrates the obstructing device in place within
air passageway 50. Obstructing member 90 has expanded upon
placement in the air passageway 50 to seal the air passageway 50.
This causes the lung portion 66 to be maintained in a permanently
collapsed state. The obstructing member 90 may be any shape
suitable for accomplishing its purpose, and may be a solid material
or a membrane.
[0047] More specifically, the obstructing member 90 has an outer
dimension 91, and when expanded, enables contact with the air
passageway inner dimension 51. This seals the air passageway upon
placement of the obstructing member 90 in the air passageway 50 for
maintaining the lung portion 66 in the collapsed state. As
described below, obstructing member 90 is arranged to permit mucus
transport from collapsed lung 66 while sealing the air passageway
50.
[0048] Alternatively, the lung portion 66 may be collapsed using
vacuum prior to placement of obstructing member 90, or it may be
collapsed by sealing the air passageway 50 with obstructing member
90. Over time, the air within the lung portion 66 will be absorbed
by the body and result in the collapse of lung portion 66.
Alternatively, obstructing member 90 may include a one-way valve
allowing air to escape from lung portion 66 but precluding air from
being inhaled. Lung portion 66 will then collapse, and the valve
will prevent air from being inhaled.
[0049] A function of the intra-bronchial device disclosed and
claimed in this specification, including the description and the
claims, is described in terms of collapsing a lung portion
associated with an air passageway to reduce lung volume. In some
lungs, a portion of a lung may receive air from collateral air
passageways. Obstructing one of the collateral air passageways may
reduce the volume of the lung portion associated with the air
passageway, but not completely collapse the lung portion as that
term may be generally understood. In other situations, obstruction
of an air passageway may not result in a complete collapse of the
lung portion, but still may provide the benefits of lung volume
reduction. As used in the description and claims herein, the
meaning of "collapse" includes a complete collapse of a lung
portion, a partial collapse of a lung portion, and a reduction of
lung volume.
[0050] FIG. 6 illustrates additional details about a bronchial
wall, a mucus layer, and an obstructing member. Bronchial wall 100
includes an epithelial membrane 97 with cilia (not shown), also
known as respiratory epithelium or epithelial layer, on the inside
or air passageway side. The epithelial membrane is coated with
mucus layer 110, which traps inhaled particles. The inhaled
particles are moved out of the respiratory system by the mucus
transport system 55 as described in FIG. 2.
[0051] In this embodiment, obstructing member 90 generally has
conical configuration, and may be hollow. More specifically, the
obstructing member 90 includes a segmented periphery that renders
it generally circular at its base, referred to herein as circular
base cross-section 94. The obstructing member 90 further includes a
circumferential, generally conical sidewall 96 that extends from
the outer periphery of generally circular cross-section base 94.
The sidewall 96 has an exterior perimeter surface 98 that defines
the outer periphery of the obstructing member 90. The obstructing
member 90 is arranged so that a portion of its outer periphery
contacts mucus layer 110 of bronchial wall 100 at a plurality of
contact areas 115 to form a loose seal that precludes air from
moving past obstructing member 90, while permitting mucus transport
system 55 to continue.
[0052] FIG. 7 is a longitudinal section view that illustrates
additional detail related to the contact areas 115 formed by the
intersection of obstructing member 90 and mucus layer 110.
[0053] FIG. 8 illustrates additional details of a preferred
embodiment of an obstructing member. The obstructing member 90
includes a plurality of inner resilient reinforcement ribs 99. The
quantity, composition, and location of inner resilient
reinforcement ribs 99 may be varied as necessary, taking into
consideration the size of the air passageway to be sealed, the
materials comprising the obstructing member 90, and other relevant
factors. Exterior perimeter surface 98 may comprise a membrane.
[0054] FIG. 9 is a cross-sectional view of the obstructing member
90 of FIG. 8 placed in an air passageway and providing for mucus
transport. When the obstructing member 90 is placed in an air
passageway, the reinforcement ribs 99 expand to create a series of
relatively flat areas 95 and ridges 93 around the exterior
perimeter surface 98. The ridges 93 press loosely against the
epithelial membrane 97 and bronchial wall 100 to form contact areas
115. The ridges 93 hold the obstructing member 90 in position
within the bronchial sub-branch by contact areas 115 on the
epithelial membrane 97 and the underlying bronchial wall 100. The
relatively flat areas 95 of exterior perimeter surface 98 and the
relatively curved wall of bronchial wall 100 form peripheral
pathways 113 for mucus 110 to flow past the obstructing member 90,
thus permitting mucus transport 55 from the lung portion to be
collapsed.
[0055] FIGS. 10-13 illustrate an alternative embodiment where the
intra-bronchial device includes an obstructing member carried on a
stent-like anchor having a ring shape. FIG. 10 illustrates the
stent-like anchor 120 and the obstructing member 90 positioned
within air passageway 50. The stent-like anchor 120 and obstructing
member 90 may each be made of any compatible materials and in any
configuration known in the art suitable for placement in an air
passageway by any suitable technique known in the art. Stent-like
anchor 120 is anchored on bronchial wall 100 by a forced fit. To
that end, the stent-like anchor 120 may be balloon expandable as is
known in the art, or may be self-expanding. In a preferred
embodiment, stent-like anchor 120 and obstructing member 90 are
coupled at a plurality of coupling areas 130 before placement into
air passageway 50. They may be coupled by any means appropriate for
the materials used, method of installation selected, patient
requirements, and degree of permanency selected. Coupling methods
may include friction, adhesive and mechanical joint. In an
alternative embodiment, stent-like anchor 120 and obstructive
member 90 may be coupled during placement in air passageway 50.
[0056] In a further alternative embodiment, stent-like anchor 120
may be comprise a serpentined, small tubular member. A majority of
the length of the small tubular member is orientated
longitudinally, and bends are formed were the small tubular member
reverses longitudinal direction. The longitudinal portions of the
serpentined small tubular member are arranged to contact the
interior perimeter of the air passageway upon deployment of the
anchor. The bends are arranged to be displaced centrally of the
interior perimeter of the air passageway upon deployment of the
anchor, and are further arranged to provide a mucus pathway between
the peripheral portion of the bend and the interior perimeter of
the air passageway.
[0057] FIG. 11 illustrates the stent-like anchor 120 disposed on
bronchial wall 100, with obstructing member 50 not shown for
clarity. Initially, the physical characteristics of stent-like
anchor 120 may block the epithelial membrane 97 and mucus transport
system 55. FIG. 11 illustrates the body's normal process of
re-epithelialization. Epithelial tissue 110 and cilia will grow on
stent-like anchor 120 over time, and permit mucus transport.
[0058] In an alternative embodiment, stent-like anchor 120 may be
first placed in the air passageway and disposed on the bronchial
wall 100 without obstructing member 50 being coupled to it. The
epithelial layer is allowed to become established across the
stent-like anchor 120 over time. Then the obstructing member 50 is
coupled to the stent-like anchor 120.
[0059] FIG. 12 is a transverse cross-section view of the stent-like
anchor of FIG. 11 and the obstructing member of FIG. 10 in place
and providing for mucus transport. FIG. 12 is similar to FIG. 9,
with the addition of the stent-like anchor 120 and a plurality of
coupling areas 130 for this alternative embodiment.
Re-epithelialization is illustrated across stent-like anchor 120.
Coupling areas 130 couple obstructing member 90 to stent-like
anchor 120 at a plurality of locations. In a manner similar to the
embodiment depicted in FIG. 9, the exterior perimeter surface 98 of
obstructing member 90 has a shape that includes a series of
relatively flat areas 95 between coupling areas 130. A relatively
flat area 95 of outer periphery 91 and a portion of the relatively
curved wall of stent-like anchor 120 form a peripheral pathway 113
for mucus 110 to flow past obstructing member 90, thus permitting
mucus transport 55 from the lung portion to be collapsed.
[0060] FIG. 13 is a longitudinal sectional view of a stent-like
anchor and an obstructing member placed in an air passageway, taken
through two coupling areas. Coupling areas 130 may reduce
re-epithelialization and physically obstruct mucus transport system
55. An alternative embodiment may use the minimum number of
coupling areas 130 necessary to carry obstructive member 90.
[0061] FIG. 14 is a longitudinal sectional view of a stent-like
anchor and an obstructing member placed in an air passageway, taken
midway through two relatively flat areas of obstructing member.
FIG. 14 illustrates peripheral pathways 113 formed between a
relatively flat area 95 and a relatively curved wall portion of
stent-like anchor 120 for re-epithelialization and for mucus layer
110. These peripheral pathways 113 permit mucus transport 55 from
the lung portion to be collapsed past obstructing member 90.
[0062] As can thus be seen from the foregoing, the present
invention provides an intra-bronchial device, system, and method
for permitting mucus transport from a lung being treated for COPD
by lung volume reduction. Mucus transportation is achieved by
providing an obstructive member that prevents air from being
inhaled into the lung portion being treated while providing a
pathway suitable for mucus transport.
[0063] While particular embodiments of the present invention have
been shown and described, modifications may be made, and it is
therefore intended in the appended claims to cover all such changes
and modifications which fall within the true spirit and scope of
the invention.
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